FS2 for Scarring from Burns

Recruiting at 1 trial location

Overseen By Stephanie Recker

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Birch BioMed Inc

Disqualifiers: Pregnancy, Heavy smoking, Heavy drinking, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 148

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if FS2, a special ingredient made from kynurenic acid, can reduce scarring in individuals with burn injuries requiring skin graft surgery. Researchers will apply the FS2 cream to both the new skin graft area and the donor site after healing. The study seeks to assess the safety and effectiveness of FS2 in improving scar healing. Individuals with severe burns needing a skin graft, excluding the face or genital areas, may be suitable for this trial. As a Phase 2, Phase 3 trial, this research measures FS2's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that FS2 is likely to be safe for humans?

Studies have shown that treatments like FS2 are generally safe for people. These treatments, including fibroblast growth factor, have not reported any major side effects. Research on FS2 specifically found that using a 0.05% cream on healed wounds greatly reduced scarring, indicating that FS2 is well-tolerated when applied to closed wounds. The current study examines FS2 for use after burn injuries and skin graft surgery, focusing on its safety and effectiveness in reducing scars. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for scarring from burns?

Unlike the standard care options for scarring from burns, such as silicone gel sheets and pressure garments, FS2 offers a novel approach. Researchers are excited about FS2 because it works by targeting and modulating the wound healing process at the cellular level, which could potentially lead to reduced scar formation. This treatment might streamline the healing process and improve cosmetic outcomes compared to traditional methods, which often focus on external pressure or hydration without altering the biological healing pathway.

What evidence suggests that FS2 might be an effective treatment for scarring from burns?

Research has shown that FS2, containing kynurenic acid, might help reduce scarring in people with burn injuries. Earlier studies found that using FS2 cream twice a day could potentially aid in treating keloid scars, which are thick and raised. This trial will evaluate FS2 in two treatment arms: one for skin-grafted wounds and another for donor skin graft harvest wounds. The treatment aids the healing process to improve the appearance of scars. While more information is always useful, these early results offer hope that FS2 could help reduce burn scars. ^{1 2 3 6 7}

Who Is on the Research Team?

Carlos Camozzi, MD, PHD

Principal Investigator

BirchBioMed Inc.

Are You a Good Fit for This Trial?

Adult burn patients aged 18-60 with a BMI of 15-35 kg/m2 who need skin grafts for burns, excluding the face and genitalia. Participants must be able to apply treatment creams themselves or with help, not smoke heavily, avoid heavy drinking or substance abuse recently, and have no history of keloid scarring or sensitivities to cream ingredients.

Inclusion Criteria

Clinically acceptable results in safety laboratory tests

I am willing and able to follow the study's requirements.

Able to understand the study requirements and consent without a translator

Exclusion Criteria

Recent participation in an interventional clinical trial

Heavy smoking (more than 20 cigarettes a day)

History of heavy drinking in the past month

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blinded Treatment

Participants receive either the control cream or the FS2 cream for 90 days in a double-blind manner

12 weeks

Regular assessment visits including Day 28, Day 60, and Day 90

Open-label Treatment

All participants receive FS2 cream for an additional 90 days in an open-label period

12 weeks

Regular assessment visits including Day 120 and Day 180

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FS2

Trial Overview The trial is testing a cream containing kynurenic acid (FS2) on scar formation after skin graft surgery in burn patients. The study compares FS2 cream's safety and effectiveness against a control cream when applied to both the grafted area and donor site post-healing.

How Is the Trial Designed?

Group I: Skin Grafted wound Experimental Treatment 2 Interventions

The wound site (injury)

Group II: Donor Skin Graft Harvest wound Experimental Treatment 2 Interventions

A Surgical wound

Who Is Running the Clinical Trial?

Birch BioMed Inc

Lead Sponsor

Trials

1

Recruited

70+

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials

40

Recruited

2,400+

Published Research Related to This Trial

A multicenter study involving 29 subjects with hypertrophic burn scars demonstrated that fractional ablative CO2 laser treatment significantly improved the elasticity, thickness, and overall appearance of scars, with objective measures showing improvements at a statistically significant level (P < 0.01).

Patient-reported outcomes also indicated significant reductions in pain and pruritus, and these improvements were sustained for at least 6 months after the treatment, highlighting the efficacy and lasting benefits of this laser therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. Miletta, N., Siwy, K., Hivnor, C., et al.[2022]

Fractional carbon dioxide laser treatment significantly improved the quality of postburn scars in patients with skin phototypes III to VI, with average scores increasing from 4.4 to 7.33 for physicians and from 5.35 to 7.5 for patients after one year.

While 60% of patients experienced mild hypochromia two months post-treatment, this decreased to only 15% after one year, indicating that while hypopigmentation can occur, it often resolves over time, especially in patients with darker skin types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Carbon Dioxide Laser in Patients with Skin Phototypes III to VI and Facial Burn Sequelae: 1-Year Follow-Up. Salles, AG., Luitgards, BF., Moraes, LB., et al.[2021]

In a study of 170 burn patients undergoing fractional CO2 laser therapy for hypertrophic scars, only 2.4% of treatment sessions resulted in adverse events, indicating that this therapy is generally safe.

Despite some minor side effects like increased pain and erythema, 97.1% of patients reported improvements in their scar symptoms, highlighting the efficacy of fractional CO2 laser therapy in managing hypertrophic burn scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Hypertrophic Burn Scars With Laser Therapy: A Review of Adverse Events. Won, P., Cooper, M., Gillenwater, TJ., et al.[2023]

Ablative carbon dioxide fractional laser treatment applied 2 to 3 weeks after thyroid surgery significantly improved the appearance of scars, as indicated by lower Vancouver Scar Scale scores in 23 women.

The treatment was found to be both effective and safe, with 12 out of 23 participants showing over 51% clinical improvement in scar appearance three months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early postoperative treatment of thyroidectomy scars using a fractional carbon dioxide laser. Jung, JY., Jeong, JJ., Roh, HJ., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06807021

Post-Operative Use of FS2 to Mitigate Scarring in Burn ... This study will help us understand if FS2 is safe and effective for mitigating skin scar formation in burn patients. Detailed Description. For the first 90 days ...

2. withpower.com withpower.com/trial/fs2-for-scarring-from-burns-72d8e

FS2 for Scarring from Burns · Info for Participants A multicenter study involving 29 subjects with hypertrophic burn scars demonstrated that fractional ablative CO2 laser treatment significantly improved the ...

3. nutrasource.ca nutrasource.ca/resources/news/birchbiomed-inc-announces-hamilton-health-sciences-centre-for-burn-research-in-ontario-as-first-clinical-trial-site-for-pioneering-burns-scar-treatment/

BirchBioMed Inc. announces Hamilton Health Sciences ... The objective of the study is to see how FS2 affects scar formation in people with burn injuries that need skin graft surgery. Notably, the ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37393760/

Carbon dioxide laser treatment of burn-related scarring Conclusions: AFCO2L treated scars had significantly altered scar thickness and texture 6 months post-laser and were rated better than controls on blinded photo ...

5. researchgate.net researchgate.net/publication/354447965_A_Randomized_Double-Blind_Active-_and_Placebo-Controlled_Trial_Evaluating_a_Novel_Topical_Treatment_for_Keloid_Scars

(PDF) A Randomized, Double-Blind, Active- and Placebo- ... The twice-daily application of FS2 Cream represents a potentially new and effective treatment for mature keloid scars. J Drugs Dermatol. 2021;20 ...

6. researchgate.net researchgate.net/publication/322954833_The_Safety_and_Tolerability_of_Topically_Delivered_Kynurenic_Acid_in_Humans_A_Phase_1_Randomized_Double-Blind_Clinical_Trial

(PDF) The Safety and Tolerability of Topically Delivered ... Scarring is a consequence of biological tissue repair following trauma. Currently there are no generally agreed ways to prevent scarring.

7. static1.squarespace.com static1.squarespace.com/static/5f65daaa78917549d33c4224/t/5f85690a34e31215789373d4/1602578704420/FS1+Phase+1+trial+%281%29.pdf

Journal of Pharmaceutical Sciences Significant reductions in hy- pertrophic scarring were achieved when a 0.05% w/w FS2 cream was applied once per day to closed wounds (8 mm; 3-5 days after.